The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Bn Prospec System.
| Device ID | K001647 |
| 510k Number | K001647 |
| Device Name: | BN PROSPEC SYSTEM |
| Classification | Nephelometer |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Product Code | JZW |
| CFR Regulation Number | 866.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-30 |
| Decision Date | 2000-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768012334 | K001647 | 000 |
| 00842768012303 | K001647 | 000 |
| 00842768012297 | K001647 | 000 |
| 00630414002736 | K001647 | 000 |
| 00842768008153 | K001647 | 000 |
| 00842768007781 | K001647 | 000 |